510(k) K043278
K043278 is an FDA 510(k) premarket notification submitted by Teratech Corp. for the device "TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES". The FDA issued a decision of Substantially Equivalent on Dec 13, 2004. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Teratech Corp. has 16 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 13, 2004
- Date Received
- Nov 26, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Transducer, Ultrasonic, Diagnostic
- Device Class
- Class II
- Regulation Number
- 892.1570
- Review Panel
- RA
- Submission Type
- 510(k)